PDA TR60 工艺验证：生命周期方法

1.0INTRODUCTION (1)

1.1Purpose and Scope (1)

1.2Background (1)

2.0GLOSSARY OF TERMS (6)

2.1Acronyms (9)

3.0BUILDING AND CAPTURING PROCESS

KNOWLEDGE (STAGE 1 — PROCESS DESIGN) 10

3.1Deliverables from Stage 1

Process Validation (12)

3.2Quality Target Product Profile (QTPP) (12)

3.3Critical Q uality A ttributes (13)

3.4Define the Manufacturing Process (14)

3.5Analytical Methods (20)

3.6Risk Assessment and Parameter Criticality

Designation (20)

3.7Process Characterization (23)

3.8Product Characterization T esting Plan (23)

3.9Control S trategy (24)

3.10Clinical Manufacturing Experience – Batch

Records and Production Data (25)

3.11Process Design Report (26)

3.12Process Validation Master Plan (26)

3.13Stage 1 Manufacturing and Technology

Considerations (26)

4.0PROCESS QUALIFICATION (STAGE 2) (28)

4.1Strategies for System Design and

Qualification (28)

4.1.1Engineering and Design (29)

4.1.1.1Risk A ssessment (29)

4.1.2Installation (29)

4.1.3Qualification Plan (29)

4.1.3.1Test Functions and

Acceptance Criteria (30)

4.1.4Maintaining Systems in a

State of Control (30)

4.2Process Performance Qualification (31)

4.2.1PPQ Readiness (31)

4.3Design Strategy for Process Performance

Qualification (PPQ) (33)

4.3.1Use of Prior Knowledge and Stage 1

Data t o S upport P PQ (33)

4.3.2PPQ Study Design (34)

4.3.2.1Number o f B atches (35)

4.3.2.2PPQ at Normal Operating Conditions .35

4.3.2.3PPQ Using Individual Unit Operation

Studies (36)

4.3.2.4PPQ Using Bracketing, Matrix,

and Family Approaches (36)

4.3.2.5Bracketing Approach (36)

4.3.2.6Matrix Approach (36)

4.3.2.7Family (Grouping) Approach (37)

4.3.2.8Process A nalytical T echnology (38)

4.3.2.9Sampling S trategy (39)

4.3.2.10Setting PPQ Acceptance Criteria (39)

4.4PPQ P rotocol (40)

4.5PPQ Report (42)

4.6Transition to Continued Process Verification 43

5.0CONTINUED PROCESS V ERIFICATION

(STAGE 3) (44)

5.1Establishing a Monitoring Program (44)

5.1.1Purpose and Strategy (44)

5.1.2Documenting the CPV Program (44)

5.1.3Legacy Products and Continued Process

Verification (46)

5.1.4Demonstrating Continued Process

Verification (47)

5.1.5CPV M onitoring P lan (48)

5.1.6Data Analysis and Trending (48)

5.2Incorporation of Feedback f rom

CPV M onitoring (49)

5.2.1Quality Systems and C PV (49)

5.3CPV Data Review and Reporting (50)

6.0PROCESS VALIDATION ENABLING SYSTEMS

AND TECHNOLOGY (51)

6.1Application of R isk Management (51)

6.1.1Risk Management in Stage 1 –

Process Design (52)

6.1.2Risk Management in Stage 2 –

Process Qualification (53)

6.1.3Risk Management in Stage 3 –

Continued Process Verification (54)

6.1.4Raw Material Risk Management

Considerations (54)

6.2Statistical Analysis Tools (55)

6.2.1Design of Experiments (DoE) (57)

6.2.2Statistical Process Control and Process

Capability (59)

6.2.2.1Statistical Process C ontrol C harts (60)

6.2.2.1.1Factors to Consider in Designing a

Control Chart (62)

6.2.2.1.2Types of Control Charts (62)

6.2.2.1.3Process Capability (62)

6.2.3Statistical Acceptance Sampling (64)

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